Launched in 1997, our Clinical Trials Office incorporates experts conducting clinical trials at the Vall d’Hebron University Hospital’s (HUVH) Medical Oncology Department, the Vall d’Hebron Barcelona Hospital Campus. Headed by VHIO’s Director, Josep Tabernero, our team comprises study coordinators, data managers, sample managers, administrative as well as quality control staff, who coordinate phase I–IV clinical studies and also participate in several translational research projects at VHIO.
Organized into three groups, covering all tumor types and studies, our personnel are managed by the Clinical Trials Office Director, Gemma Sala.
In 2019 we managed 1 phase 0, 139 Phase I, 23 Basket studies, 141 phase II, and 121 phase III clinical trials with active recruitment throughout the year (see Figure), with patient enrolment totaling at 1122. 150 new trials were initiated, including 8 post-authorization trials and rollover studies. In addition, we continue to follow up patients who were recruited prior to 2019 and are still enrolled and receiving study treatment (more than 900 patients in total, and more than 1400 in follow up).
More than half of our patients included in our Phase I Clinical Trials have been referred to us from other Hospitals, which has consequently positioned our Unit as leading reference in early clinical studies.
As a reflection of our continued expansion as well as recognition of excellence, we have undergone 16 audits with positive results and VHIO’s Research Unit for Molecular Therapy of Cancer (UITM) –”la Caixa”, directed by Elena Garralda, has been reaccredited by the Generalitat de Catalunya.
As we continue to render personalized medicine more precise by matching therapies to respond to the specificities of each individual patient, each individual tumor, the requirements and selection criteria for inclusion in certain studies are also becoming more complex.
While we are dedicated to expanding our portfolio of trials in order to ultimately establish new treatment models with highly selective drugs, we continue to fine-tune patient selection criteria in order to best identify those patients who are most likely to benefit from novel therapies, including emerging immune-based therapies, tailored to individual patients’ molecular ‘measurements’.
The prestige of our Hospital’s Medical Oncology Department is increasingly recognized by pharmaceutical as well as biotechnology companies. It has also become a reference program and selected by the industry to carry out complex clinical trials for which the number of participating centers is highly restricted.
Clinical sites are selected based on the highest standards of quality and capacity for carrying out state-of-the-art research. We have participated in early phase trials of different drugs, ultimately enabling the pharmaceutical industry to market novel anti-cancer medicines. We are involved in studies promoted by the pharmaceutical industry as well as those developed by us in collaboration with other hospitals. We have also conducted more than 10 Investigator-Initiated Trials (IITs).
Inaugurated in June 2010, thanks to the support received from the ”la Caixa” Foundation, the Research Unit for Molecular Therapy of Cancer (UITM) –”la Caixa”, is dedicated to complex clinical trials with drugs in early development (phase I and early phase II trials), focusing on novel targets. Occupying a total surface area of 1000 m2 our Unit is located within the General Area of the Vall d’Hebron University Hospital (HUVH), the Vall d’Hebron Barcelona Hospital Campus.
This privileged environment with direct access to patients, coupled with VHIO’s translational approach to research and superb scientific framework, has enabled our Unit to rapidly establish itself as one of the few comprehensive facilities in Europe to rapidly transform latest discovery into benefits for patients.
By promoting tight connectivity between oncology care and research we establish novel treatment models for patients with highly selective drugs, and advance insights into tumor diseases and how to treat them in an individualized way – getting the right therapy to the right patient at the right time. As the figures show, we are gradually doing so for an increasing number of patients.
In 2019, also thanks to the support received from the ”la Caixa” Foundation, the building of VHIO’s Clinical Research Oncology Pharmacy’s Unit’s (led by Maria Queralt), new Facility, the Research Unit for Molecular Therapy of Cancer (UITM) – ”la Caixa”- Clinical Research Onco-Hematology Unit was completed. Equipped with all with all the very latest technologies, this will enable them to provide even higher quality pharmaceutical care and continue to respond to all regulatory requirements.
This year, our Unit has participated in 162 ongoing phase I clinical trials, 23 of which are Basket trials. Our facilities, coupled with our multidisciplinary clinical teams, enable us to continue to expand our portfolio of phase I studies. This year we opened 46 new trials; 6 as Baskets. 499 patients were recruited, 241 of whom were enrolled in immunotherapy clinical trials.
Research carried out at our Unit by VHIO’s Early Clinical Drug Development Group directed by Elena Garralda, centers on the development of new drugs based on the molecular profile of each tumor as well as the optimization of treatment regimens using combinations of new agents with those that already exist.
Reflective of VHIO’s purely translational model, our studies are also linked to several research lines led by other VHIO groups, thus connecting molecular biology and optimal tumor models with pharmacology and innovative clinical research. VHIO scientists also collaborate closely in our trials to facilitate biomarker development, a deep understanding of the mechanism of action, as well as research into mechanisms of cancer drug resistance.
In partnership with VHIO’s Cancer Genomics (PI Ana Vivancos), Molecular Oncology (PI Paolo Nuciforo), and Oncology Data Science - ODysSey (PI Rodrigo Dienstmann), together with Susana Aguilar and Jenifer Gonzalez, we perform molecular analyses of patients’ tumors to select the best possible treatment with the experimental therapeutics available. Thanks to our Cancer Genomics Group’s development of existing applications for faster results including an n-Counter (Nanostring) platform, two digital PCR platforms (BEAMing Sysmex and ddPCR, BIO-RAD), and two NextGen Sequencers; MiSeq and HiSeq2500 (Illumina) we continue to drive faster and more precise mutational analyses of tumor suppressor genes as well as translocations and gene amplifications.
UITM incorporates a multidisciplinary team comprised of medical oncologists, clinical trial coordinators and data managers, nurses and nurse technicians, pharmacists, as well as administrative personnel.
Excellent patient treatment and care as well as pioneering research is also made possible thanks to the collaboration of many other oncology professionals including our team of Clinical Research Oncology Nurses led by Mª Angeles Peñuelas, pathologists from the Vall d’Hebron University Hospital’s Molecular Pathology Department, radiologists and interventional radiologists, as well as our Clinical Trials Office and Database Management, directed by Gemma Sala, Clinical Research Oncology Pharmacy Unit headed by Maria Queralt, and other healthcare specialists including dermatologists, cardiologists, and ophthalmologists.
Clinical trials in oncology are essential for the identification of novel, more effective targeted therapies against cancer as well as improving survival, side effect profiles and the quality of life of patients. Advances in oncology care and the development of more powerful anti-cancer medicines are driven by optimal processes in clinical trials.
Our expert clinical research oncology nurses assume a central role by undertaking a variety of roles including identifying trends in side effects, closely collaborating with multidisciplinary teams to develop and evaluate patient management, contributing to clinical studies by collating samples and quality data, as well as providing excellence in nursing care and symptom management for all patients enrolled in clinical trials.
VHIO's Clinical Research Oncology Nurses, specialized in molecular therapies, are headed by Angeles Peñuelas and represent an important element of the multidisciplinary teams involved in the studies performed and coordinated at VHIO's Research Unit for Molecular Therapy of Cancer (UITM) – ”la Caixa” and Clinical Trials Office, directed by Elena Garralda and Gemma Sala, respectively.
Supporting these teams comprised of medical oncologists, molecular pathologists, oncology pharmacists, clinical researchers, and study coordinators, VHIO's oncology nurses are key to ensuring the delivery of optimal care for patients who receive the full range of expertise, guidance, and the necessary follow-up throughout the course of their participation in a clinical study.
As importantly is the psychological support they provide, alongside the other superbly trained oncology care givers and specialists including psychologists. Our nurses also provide patients and their families with the information and professional guidance they need to make fully informed decisions concerning their treatment options.
In 2019, across the 425 actively recruiting trials patient enrollment totaled at 1122. Our clinical teams also continue to follow up patients that were recruited prior to 2019 who are still enrolled and receiving treatment.
As VHIO continues to expand its portfolio of clinical trials to ultimately establish novel treatments with highly selective drugs, and fine-tune patient selection criteria in order to identify those patients who are most likely to benefit from them, we can expect a steady increase in patient recruitment across our clinical studies in the future.
Our Unit is ISO 9001:2015 certified and affiliated with the Medical Oncology Service of the Vall d’Hebron University Hospital (HUVH), Vall d’Hebron Barcelona Hospital Campus. As noted in our Highlights section above, thanks to the support received from the ”la Caixa” Foundation, the building of our new Facility, the Research Unit for Molecular Therapy of Cancer (UITM) – ”la Caixa”- Clinical Research Onco-Hematology Unit was completed. Equipped with all with all the very latest technologies, this will enable us to provide even higher quality pharmaceutical care and continue to respond to all regulatory requirements.
We focus on two main areas of clinical research in oncology:
Oncology Pharmaceutical Care Program
Our team of pharmacists specialized in hospital pharmacy and oncology pharmacy and our laboratory technicians prepare cytostatics and other parenteral therapies used in clinical trials. They also monitor and follow-up patients.
Pharmacological Research in Oncology Support Program
This program is led by our team of pharmacists and laboratory technicians specialized in clinical trials, who are responsible for study supplies management, storage, dispensation, and traceability control.
In 2019 we managed drugs used in 591 active clinical trials in oncology & hematology, and 7.426 resupply deliveries/clinical trials supplies receptions. We continue to benefit from our cutting-edge system for controlling storage temperature which, performing electronic temperature recordings every 5 minutes daily, displays readings on computers equipped with audiovisual alarms as well as an around-the-clock SMS alert system to monitor and report temperature deviations.
Regarding the design and validation of our drug preparation process traceability system, we ensure qualitative and quantitative quality control of our computerized system.
In 2019 our dispensing staff actively participated in 113 pre-study visits, 185 initial visits, 1,841 monitoring visits, 111 close-out visits. We have also successfully passed 21 audits, 1 mock inspection, 1 ISO inspection, and 1 inspection by local regulatory authorities for reaccreditation of our Oncology Phase I Unit.
Additionally, 39,055 clinical trial drugs have been dispensed and validated by our pharmacists, 13,782 of which were for oral administration, 1,017 for IM/ subcutaneous administration, and 24,256 for IV administration. A total of 214 Standardized Dispensing Procedures for clinical trials have been drawn up and we have performed 892 updates of these procedures due to subsequent amendments to protocols or pharmacy manuals. 156 storage temperature data reports have also been prepared by our dispensing team.
Preparations of cytostatics, monoclonal antibodies and other parenteral antitumor drugs for clinical trials totaled at 24,122. We also included 432 antineoplastic therapeutic schedules in our prescription software.
Our Pharmaceutical Care Program for patients enrolled in phase I clinical trials: we performed 1,205 visits, 253 screenings, 238 C1D1s, and 221 follow-ups, also compiling patient diaries and/or instructions for patients (in the absence of documentation provided by the respective sponsor).
We have also compiled 15 different diaries and 15 instruction manuals for patients enrolled in the phase I studies involving orally administered drugs by our preparation staff. We also prepared 23 diaries and patient manuals for phase II and phase III clinical trials in 2019 for patients enrolled in all phase II and III studies involving orally administered drugs by our dispensing staff.